Positioning and alignment instrument for introducing surgical devices into bone

ABSTRACT

A positioning and alignment instrument, and methods of use thereof, are provided for facilitating the alignment and insertion of a device, such as a guide wire, into bone. The instrument includes a handheld anchoring component and a rotatable guidance component. During use, the anchoring component is anchored into bone via anchoring protrusions, such that the position and orientation of the anchoring component is fixed relative to the bone. The guidance component, which is mechanically supported by the anchoring component, includes a device guide channel for receiving the device and guiding the device towards an insertion location adjacent to the distal end of the anchoring component. The guidance component is rotatable relative to the anchoring component about a rotation axis that is located adjacent to the distal end of the anchoring component, such that the insertion location remains adjacent to the distal end of the anchoring component under rotation.

CROSS-REFERENCE TO RELATED APPLICATION

This application claims priority to U.S. Provisional Application No.62/297,571, titled “POSITIONING AND ALIGNMENT INSTRUMENT FOR INTRODUCINGSURGICAL DEVICES INTO BONE” and filed on Feb. 19, 2016, the entirecontents of which is incorporated herein by reference.

BACKGROUND

Intramedullary (IM) nailing is a minimally invasive surgical proceduretypically performed under a general anesthetic and with fluoroscopicimage guidance. The surgical phases associated with this type of surgeryare well defined: patient preparation, access to the bone entry site, IMguide wire insertion (including fracture reduction for guide wireplacement), IM nail placement, locking of the nail to control rotationand length, final clinical and radiographic assessment of fracturereduction/restoration of length/alignment/rotation, and surgical woundclosure. Yet, despite widespread usage of IM nailing, significantsurgical challenges may arise. Such challenges can significantly impedethe surgical workflow, requiring additional operative time and radiationexposure to both patients and medical staff. Fracture reduction andproper localization for initial IM access are particularly challengingareas in the workflow pathway. Lengthy delays in the procedure andunacceptable fracture reduction or stabilization can also significantlyendanger patient safety, particularly in those who may suffer frompolytrauma and/or acute respiratory issues.

SUMMARY

A positioning and alignment instrument, and methods of use thereof, areprovided for facilitating the alignment and insertion of a device, suchas a guide wire, into bone. The instrument includes a handheld anchoringcomponent and a rotatable guidance component. During use, the anchoringcomponent is anchored into bone via anchoring protrusions, such that theposition and orientation of the anchoring component is fixed relative tothe bone. The guidance component, which is mechanically supported by theanchoring component, includes a device guide channel for receiving thedevice and guiding the device towards an insertion location adjacent tothe distal end of the anchoring component. The guidance component isrotatable relative to the anchoring component about a rotation axis thatis located adjacent to the distal end of the anchoring component, suchthat the insertion location remains adjacent to the distal end of theanchoring component under rotation.

Accordingly, in one aspect, there is provided a positioning andalignment instrument for guiding insertion of a device into bone, thepositioning and alignment instrument comprising:

an anchoring component comprising a proximal portion and a distalportion, wherein said proximal portion comprises a handle, and whereinone or more anchoring protrusions extend from a distal end of saiddistal portion for anchoring said anchoring component into the bone,such that a position and an orientation of said anchoring component isfixed relative to the bone when said anchoring component is anchored tothe bone; and

a guidance component mechanically supported by said anchoring component,said guidance component comprising a device guide channel for receivingthe device and guiding the device towards an insertion location adjacentto the distal end of said anchoring component;

wherein said guidance component is rotatable relative to said anchoringcomponent about a rotation axis that is located adjacent to the distalend of said anchoring component, such that the insertion locationremains adjacent to the distal end of said anchoring component underrotation of said guidance component.

In another aspect, there is provided a method of employing fluoroscopyto aligning a device during a medical procedure, the method comprising,after having employed fluoroscopy, in a first direction, to anchor thepositioning and alignment instrument into bone:

obtaining fluoroscopy images of the positioning and alignment instrumentin a perpendicular direction; and

rotating the guidance component to a desired angle according to thefluoroscopy images; and

thereby aligning the device guide channel for subsequent guidance andinsertion of the device into the bone.

A further understanding of the functional and advantageous aspects ofthe disclosure can be realized by reference to the following detaileddescription and drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments will now be described, by way of example only, withreference to the drawings, in which:

FIGS. 1A and 1B show views of an example positioning and alignmentinstrument.

FIG. 1C shows a detailed view of the distal region of the positioningand alignment instrument.

FIG. 1D illustrates an alternative embodiment in which the guidancecomponent is rotatably supported by the anchoring component such thatthe rotation axis lies distalward relative to the distal end 118 of theanchoring component.

FIG. 1E shows a detailed assembly view of the rail that is provided inthe proximal portion of the guidance component.

FIG. 1F shows an alternative implementation of the orientation of thehandle.

FIG. 1G shows a detailed view of the distal region of the anchoringcomponent, illustrating an example embodiment in which the position ofthe rotation pin is adjustable relative to the anchoring component.

FIGS. 2A-2C show the use of an example force coupling tool for applyingan impact force to drive the anchoring protrusions of the anchoringcomponent into bone.

FIGS. 2D-2E illustrate the use of an alternative force coupling toolthat is configured to drill the anchoring protrusions into bone.

FIGS. 3A-3E illustrate the steps and challenges in conventionalKirschner wire (K-wire) positioning and alignment. FIG. 3A shows aninitial anterior-posterior (AP) image with a correct entry pointlocation and orientation. Perpendicular lateral images through thesagittal plane show the following: FIG. 3B: correct location, incorrectorientation, requiring AP rotation; FIG. 3C: incorrect location, correctorientation, requiring AP translation; and FIG. 3D: incorrect locationand orientation of the entry point, requiring AP rotation andtranslation to obtain correct lateral entry point location andorientation, shown in FIG. 3E.

FIG. 4 is a flow chart illustrating an example method in which aposition and alignment instrument is employed a medical procedureinvolving the introduction of a device into bone.

FIGS. 5A-5C show fluoroscopy images of the positioning and alignmentinstrument during various steps of the method illustrated in FIG. 4.

FIG. 5D shows the two-dimensional array of device guide channels visibleat the proximal end of the rotatable guidance component.

FIG. 6 shows a fluoroscopy image showing the introduction of a Kirschnerwire into bone following the positioning and alignment of the Kirschnerwire using an example positioning and alignment instrument.

FIG. 7 shows the use of an example positioning and alignment instrumentduring the insertion of a locking screw into the distal end of anintramedullary rod during an intramedullary nailing procedure.

FIG. 8 shows an expanded view relative to FIG. 7, showing theorientation of the C-arm relative to the example positioning andalignment instrument.

FIG. 9 shows an example alternative configuration of an anchoringprotrusion.

DETAILED DESCRIPTION

Various embodiments and aspects of the disclosure will be described withreference to details discussed below. The following description anddrawings are illustrative of the disclosure and are not to be construedas limiting the disclosure. Numerous specific details are described toprovide a thorough understanding of various embodiments of the presentdisclosure. However, in certain instances, well-known or conventionaldetails are not described in order to provide a concise discussion ofembodiments of the present disclosure.

As used herein, the terms “comprises” and “comprising” are to beconstrued as being inclusive and open ended, and not exclusive.Specifically, when used in the specification and claims, the terms“comprises” and “comprising” and variations thereof mean the specifiedfeatures, steps or components are included. These terms are not to beinterpreted to exclude the presence of other features, steps orcomponents.

As used herein, the term “exemplary” means “serving as an example,instance, or illustration,” and should not be construed as preferred oradvantageous over other configurations disclosed herein.

As used herein, the terms “about” and “approximately” are meant to covervariations that may exist in the upper and lower limits of the ranges ofvalues, such as variations in properties, parameters, and dimensions.Unless otherwise specified, the terms “about” and “approximately” meanplus or minus 25 percent or less.

It is to be understood that unless otherwise specified, any specifiedrange or group is as a shorthand way of referring to each and everymember of a range or group individually, as well as each and everypossible sub-range or sub-group encompassed therein and similarly withrespect to any sub-ranges or sub-groups therein. Unless otherwisespecified, the present disclosure relates to and explicitly incorporateseach and every specific member and combination of sub-ranges orsub-groups.

As used herein, the term “on the order of”, when used in conjunctionwith a quantity or parameter, refers to a range spanning approximatelyone tenth to ten times the stated quantity or parameter.

Referring now to FIG. 1A, an example positioning and alignmentinstrument 100 is shown, where the instrument 100 is configured forfacilitating the alignment and insertion of a device, such as a guidewire (not shown), into bone. The instrument 100 includes a handheldanchoring component 110 and a rotatable guidance component 120. Duringuse, the anchoring component 110 is anchored into bone via anchoringprotrusions 115, such that the position and orientation of the anchoringcomponent 110 is fixed relative to the bone. The distal surface 118 ofthe anchoring component 110, from which the anchoring protrusions 115extend, contacts the bone upon insertion of the anchoring component 110into the bone, thereby establishing a reference location at the bonesurface. In the example embodiment shown in FIGS. 1A and 1B, the distalend 118 of the anchoring component 110 has a rectangular cross-section.

In the present example embodiment, the rotatable component 120 is amulti-cannulated arm that includes a plurality of device guide channels122, where each device guide channel has a diameter suitable forreceiving and guiding a device (e.g. a guide wire) as the device isadvanced towards the bone. As shown in FIGS. 1A and 1B, each deviceguide channel 122 extends, through the rotatable guidance component 120,from a proximal end 124 to a distal end 126. As described in detailbelow, the optional inclusion of a plurality of device channel guides122, arrayed in one or two dimensions, provides a surgeon with theability to select a suitable device guide channel for device insertionin order to obtain a desired entry location relative to the anchoringlocation (the location in the bone that is adjacent to the distal end ofthe anchoring component 110). The diameters of the various device guidechannels 122 may be identical or different, and may vary in terms ofdiameter, pattern and number.

For applications involving the use of fluoroscopy, such as thosedescribed below, at least a distal region of the rotatable guidancecomponent 120 may be radiolucent, such that the device guide channels122 and/or a device inserted within a given device guide channel 122 isobservable. In such applications, it may be preferable for the distalends of both the rotatable guidance component 120 and the anchoringcomponent 110 to be radiolucent. For example, the distal region of theanchoring component 110 may include a radiolucent segment 110A. One ofboth of the rotatable guidance component 120 and the anchoring component110 may include a radiopaque material in order to identify one or morefeatures or locations of the positioning and alignment instrument.

The rotatable guidance component 120 is rotatable relative to theanchoring component 110, in order to vary the angular orientation ofdevice channel guides 122 relative to the anchoring location, therebyenabling the selection of a suitable orientation for insertion (entry)of the device into the bone (e.g. a suitable angular orientationrelative to the bone, or to internal anatomical features or structures,or to an internal medical device). As shown in FIGS. 1A and 1B, therotatable guidance component 120 rotates about a rotation axis 130 thatis located adjacent to the distal end 118 of the anchoring component110. As used herein, the phrase “adjacent to the distal end 118 of theanchoring component” refers to a location that is at, or is proximal to,the distal end 118 of the anchoring component 110, such as within 5 mm,within 4 mm, within 3 mm, within 2 mm, or within 1 mm, of the distal endof the anchoring component. It will be understood that a suitablemaximum offset of the rotation axis 130 relative to the distal end 118of the anchoring component 110 may depend on clinical application. Forexample, in the case of the insertion of a guidewire (e.g. a Kirschnerwire) during an intramedullary nailing procedure, a suitable maximumoffset may be 10 mm.

By rotatably securing the rotatable guidance component 120 to theanchoring component 110 such that the rotation axis 130 lies adjacent tothe distal end 118 of the anchoring component 110, the entry location ofthe device remains adjacent to the distal end of the anchoring component110 over a wide range of rotation angles of the rotatable component 120about the rotation axis 130. This aspect of the rotatable guidance 120component differs significant from known devices in which an externalrotatable component is rotatable about a rotation axis that isconfigured to lie within the patient anatomy, at a locationcorresponding to an internal anatomical feature.

In one example implementation, the rotation axis 130 may be located atthe distal end 118 of the anchoring component 110, such that therotation axis 130 lies within the plane of the distal surface 118. Inanother example embodiment, the rotation axis 130 may be located at alocation that is proximal to the distal end 118 of the rotatableguidance component 120 (such that the rotation axis 130 passes throughthe distal region of the anchoring component. For example, this may beachieved by providing, at a location that is adjacent to the distal endof the anchoring component 118, a rotation pin 301 about which therotatable guidance component 120 is confined to rotate.

An example of such a configuration is shown in FIG. 1C, where a rotationpin 301 is housed inside the anchoring component 110 to guide therotatable guidance component 120 via a connecting plate 302. Theconnecting plate 302 is attached to the rotatable guidance component 120and the anchoring component 110. The connection plate 302 is secured tothe anchoring component 110 using a screw 303 and rigidly attached tothe rotatable guidance component 120 with two or more screws 304.

In yet another example embodiment, the anchoring component 110 and therotatable guidance component 120 may be configured such that therotation axis 130 lies distalward relative to the distal end 118 of theanchoring component 110. For example, such a configuration is shown inFIG. 1D, where a supporting mechanism 305 is attached to the rotatableguidance component 120 and the anchoring component 110.

The positioning and alignment instrument 100 may include a rotationactuation mechanism for actuating rotation of the rotatable guidancecomponent 120. In the example implementation shown in FIGS. 1A and 1B,the rotation actuation mechanism is located proximal to a handle 135,where the handle forms or is attached or otherwise connected to aproximal portion of the anchoring component 110.

The rotation actuation mechanism may be positioned such that it issuitable for single-handed actuation by a user while holding the handlewith a single hand. FIGS. 1A and 1B illustrate an example rotationactuation mechanism that includes a knob 150 that engages with a setscrew 152 that is provided in a rotatable connection shaft 154, suchthat when the knob 150 is rotated, the connection shaft 154 is rotated.

The rotation of the knob 150 produces corresponding rotation of theconnection shaft 154, which in turn rotates linkage shaft 156, to whichthe connection shaft 154 is connected. The linkage shaft 156 extends ina distalward direction relative to the connection shaft 154, and aconnection pin 158 extends from the linkage shaft 156 at or near itsdistal end. The connection pin 158 is received and secured with a screw306 within a rail 160 provided in a proximal portion of the rotatableguidance component 120 as shown in assembly view in FIG. 1E. Therotatable guidance component 120, which is confined to rotate about therotation axis 130 as described above and illustrated in FIG. 1C, thusrotates about the rotation axis 130 when the knob 150 is rotated, viathe coupling of the rotational motion through the connection shaft 154,the linkage shaft 156, and the confined travel of the connection pin 158within the rail 160. The proximal location of the knob 150 relative tothe handle enables single-handed rotational actuation.

In some example embodiments, the rotatable guidance component 120 may beoptionally and removably locked in a fixed angular configuration by arotation locking mechanism, such that the rotatable guidance component120 is only rotatable when the rotation locking mechanism is actuated bythe operator. An example rotation locking mechanism is illustrated inFIGS. 1A and 1B. When the locking trigger 170 is not actuated by theoperator, a first gear 162 formed in or attached to the knob 150 isbiased, by a spring 164 and a set screw 166, to engage with a secondgear 166 that is fixed relative to the anchoring component 110. When theoperator applies a force to the trigger 170, the first gear 162 isdisengaged from contact with the second gear, thus permitting rotationof the knob 150. This example locking mechanism is capable ofsingle-handed actuation.

It will be understood that the rotation mechanism and the rotationactuation mechanism that are illustrated in FIGS. 1A and 1B are providedto illustrate merely one example implementation, and that a wide varietyof alternative rotation mechanisms and rotation actuation mechanisms maybe employed without departing from the intended scope of the presentdisclosure.

Examples of alternative rotation mechanisms and configurations include,but are not limited to a mechanism where the rotating knob 150 is placedperpendicular to its current configuration and a gear mechanism is usedto transmit the rotational movement.

Examples of alternative rotation actuation mechanisms and configurationsinclude, but are not limited to, (i) a motorized mechanism where a pushof a button turns the motor in clockwise and/or counterclockwisedirections which in turn rotates the connection shaft 154, and (ii) adirect rotation of the rotational guidance component 120.

Furthermore, examples of alternative rotation locking mechanismsinclude, but are not limited to, (i) a ratcheting mechanism where themovement of the rotatable knob 150 is constrained in clockwise and/orcounterclockwise directions, and (ii) a magnetic mechanism where theattraction of opposite magnetic poles restricts the rotational movementof the connecting shaft 154.

FIG. 1F shows an alternative implementation of the anchoring component,where the handle, rotation knob, and locking mechanism are positioned ina different configuration than in the previous embodiments.

In some example embodiments, the guidance and alignment instrument maybe further configured to permit one or more additional degrees offreedom in the alignment of the guidance component relative to theanchoring component. For example, as illustrated in FIG. 1G, theposition of the rotation pin 301 may be adjustable relative to theanchoring component 110. Such an embodiment may permit lateraladjustment of the location of the rotation axis once the anchoringcomponent 110 is anchored into bone. In other example embodiments, therotation pin 301 may be adjustable in other directions, such as alongthe longitudinal direction of the anchoring component 110.

In order to anchor the anchoring component 110 into the bone, a forcemust be applied with sufficient magnitude in order to cause theanchoring protrusions to penetrate the bone surface and become embeddedin the bone. This may be achieved by applying a force, such as with ahammer or other suitable tool, to a proximal surface of the anchoringcomponent 110. In some example embodiments, a suitable proximal surfacemay be accessible regardless of the orientation of the rotationalguidance component 120.

However, in the example implementation shown in FIGS. 1A and 1B, theproximal surface of the anchoring component 110 is substantiallyoccluded by the rotational guidance component 120 when the rotationalguidance component 120 is aligned with the anchoring component 110 (thisaligned configuration is shown in FIG. 1B). Therefore, it may benecessary to rotate the rotatable guidance component 120 to asufficiently large angle in order to provide access to a suitableproximal surface for delivering an impact force thereto. An example ofsuch an orientation is shown in FIG. 1A, where the rotatable guidancecomponent is rotated to a sufficiently large angle to provide access toproximal surfaces 172 and 174. This proximal region may be configured topresent a single surface that is suitable for receiving an impact forcefrom a tool such as a hammer.

In another example implementation, a force coupling tool may be employedto temporarily and removably contact the anchoring component 110, suchthat a force applied to a proximal surface of the force coupling tool iscoupled to the anchoring component 110 via contact therewith. An exampleof such an embodiment is shown in FIGS. 2A-2C.

FIG. 2A shows an example embodiment in which the positioning andalignment instrument is contacted with a force coupling tool 200. Theexample force coupling tool slides overtop of the proximal portion ofthe anchoring component 110 (and, in this example case, the proximalportion of the rotatable guidance component 120). A distal surface 210of the force coupling tool 200 abuts against the proximal surface 172 ofthe anchoring component 110 (a similar abutment occurs on the oppositeside of the device with proximal surface 174). This abutment providescontact such the application of a force (e.g. an impact force) to theproximal surface 205 of the force coupling tool 200 is coupled (e.g.communicated; transferred) to the anchoring component 110, and isthereby also transferred to the anchoring protrusions 115. The proximalsurfaces 172 and 174 (or a single proximal surface) of the anchoringcomponent may be established by a separate component that is attached tothe anchoring component 110, or may be integrally formed as surfaces ofthe anchoring component 110.

FIG. 2B shows the positioning and alignment instrument, having the forcecoupling tool 200 provided thereon (e.g. contacted therewith or attachedthereto), with the anchoring protrusions 115 positioned at a suitablelocation for insertion into the bone 10. Upon the delivery of a suitableforce to the proximal surface 205 of the force coupling tool 200, asshown in FIG. 2C, the anchoring protrusions 118 are delivered into andanchored within the bone 10, such that the distal surface 118 of theanchoring component 110 lies adjacent to the bone surface. Theconfiguration shown in the present example embodiment, in which theforce coupling tool slides over proximal portions of both the anchoringcomponent 110 and the rotational guidance component 120, may bebeneficial in preventing rotational movement of the rotational guidancecomponent during anchoring and protecting various components (such asthe rotational guidance component 120) from impact or the application ofundue stress.

It will be understood that the force coupling tool shown in FIGS. 2A-Cprovides but one non-limiting example of a mechanism for providing aforce sufficient to deliver the anchoring protrusions into bone. Inother example embodiments, the force coupling tool may be configured fordelivery of the anchoring protrusions into the bone in the absence of animpact force.

Referring now to FIGS. 2D and 2E, an example embodiment is illustratedin which a gearbox 600 is employed to rotate the anchoring protrusions115, thereby facilitating a drilling action of the anchoring protrusions115 into bone. According to this alternative example embodiment, theanchoring of the device may be achieved by drilling the anchoringprotrusions 115 (as opposed to hammering them) into the bone.

This alternative modality for anchoring the device may be advantageous,for example, in the case of a proximal femoral fracture. In such a case,the instability of the proximal fragment can limit the ability of theanchoring protrusions to be effectively hammered into the bone. Thepresent example embodiment avoids the need to deliver the anchoringprotrusions into bone under an impact force by employing a gearbox todrill the one or more anchoring pins into the greater trochanter of thefemur, thereby facilitating the securing of the device to an unstablebony fragment.

As shown in FIGS. 2D and 2E, the force coupling tool includes a gearbox600 that contacts a proximal portion of the anchoring component 110,optionally being fixed or removably attached to the anchoring component110. The gearbox 600 houses a gear train 610 configured to rotate theone or more anchoring protrusions of the device. A proximal portion ofthe gearbox includes at least one screw 620 that is configured toactuate the gear train 610, such that when the screw 610 is rotatedduring application of a longitudinal force thereto, the longitudinalforce is coupled to the anchoring protrusions during rotation, where therotation facilitates the drilling of the anchoring protrusions intobone.

In the example embodiment illustrated in FIGS. 2D and 2E, the anchoringprotrusions are provided as elongate flexible pins 115 that extendthrough or along, and are supported by, the anchoring component 110. Thepins 115 are shown extending from a distal end of the anchoringcomponent 110 to form the anchoring protrusions. A proximal portion ofeach pin 115 extends from the proximal portion of the anchoringcomponent 110 and is received within a respective pin-receiving gear ofthe gear train 610, such that actuation of the gear train producesconcomitant rotation of the pins 115.

During use, the surgeon uses a drill to rotate the screw 620, thusactuating the gear train 610 and producing rotation of the pins 115. Thegearbox 600 translates the rotation to the other gears, and both pins115 rotate simultaneously. As the surgeon advances the screw 620, thedevice moves forward, thereby providing a simultaneous advancing forceand rotational movement to drive the pins 115 into the bone. Thisenables a rapid effective single step for attachment of the device tothe bone. The axial force applied to the screw 620 during drillingcauses the whole mechanism to advance toward the bone. The elongatedshape of the gearbox 600 enables the screws 620 to move in this axialdirection without risk of engaging the patient's skin or soft tissues.

In the example embodiment shown in FIGS. 2D and 2E, two screws (top andbottom screws) are provided on either side of the gear train 610, whereeach screw is configured to actuate the gear train 610, thus allowingthe surgeon to select a screw that is most easily accessible (e.g.depending on the side (left or right femur) that the surgeon isoperating on). It is also noted that the screws 620 sit offset from theguidance component 120, thereby allowing indirect access to the pins115, in order to enable access despite the presence of the guidancecomponent 120.

Although the present example embodiment illustrates a device in whichpins 115 are rotated by the gearbox 600, it will be understood that thepins 115 can be replaced with screws according to other exampleembodiments. For example, in one example implementation, the gearbox 600may be configured to rotationally drive one or more flexible drill bitssupported by the device. The flexible drill bits may be removable andreplaceable, thereby enabling the use of different tip attachments ofvariable shaft diameter/shape at the device/bone interface.

As shown in FIGS. 1A, 1B, and in particular, FIG. 2C, the positioningand alignment instrument may be shaped such that a proximal portionthereof deflects, bends, curves, or otherwise angles outwardly relativeto a longitudinal axis (a device guidance axis) associated with a distalregion of the rotatable guidance component 120. This geometricalconfiguration may be useful, beneficial or important in providing thesurgeon suitable ergonomic manipulation of the positioning and alignmentdevice during use. For example, when the position and alignmentinstrument shown in FIG. 2C is employed during an intramedullary nailingprocedure, the outward deflection of the proximal region of theinstrument enables the surgeon to apply an impact force to a proximalregion of the instrument without risk, or with reduced risk, ofcontacting the patient. The deflected configuration also positions thehandheld portion of the device further away from the subject than in acollinear (straight) configuration, which may provide for a moreefficient and safe surgical procedure. In some example embodiments, atleast a portion of the positioning and alignment instrument is deflected(angled) outwardly relative to the distal longitudinal axis by an anglebetween 0 and 45 degrees. It will be understood that the shape of theinstrument may vary depending on clinical application and/or anatomicalside of the subject. For example, the instrument may have differentshapes for operating on a left or right limb (e.g. for optimalpositioning of the handle).

Although the example positioning and alignment instruments describedherein may be employed for a wide variety of applications and medicalprocedures, an example method of employing such an instrument during anintramedullary nailing procedure is described below. It will beunderstood that the methods below are merely provided as beingillustrative of the application of the example positioning and alignmentinstrument embodiments disclosed herein.

FIGS. 3A-3E illustrate the cumbersome and iterative nature of aconventional intramedullary (IM) nailing procedure involving thealignment of a Kirschner wire (K-wire), where the entry point locationand orientation both have a significant impact on the overall outcome ofthe IM nailing procedure. During a conventional IM nailing procedure,fluoroscopy images are obtained in the AP direction (through the coronalplane).

Once adequate images with respect to entry point location and K-wireorientation are acquired in the AP direction (see FIG. 3A), errors insagittal placement must be addressed. If the sagittal entry pointlocation is correct but the lateral orientation is incorrect (FIG. 3B),the surgeon must alter the anterior-posterior angle of entry of theK-wire about the identified entry location (ensuring no displacement ofthe K-wire tip from the entry site). If the sagittal entry pointlocation is incorrect but the orientation is correct (FIG. 3C), thesurgeon must adjust the anterior-posterior translation along thesagittal plane without any change in sagittal angulation of the K-wire.If the sagittal entry point location and orientation are both incorrect(FIG. 3D), then the surgeon must first readjust the entry location inthe sagittal plane. Once the correct new entry location is verified withlateral fluoroscopy, the surgeon must then readjust the K-wireorientation in the sagittal plane to ensure parallelism in access to theIM canal (FIG. 3E); following this step, the surgeon needs to recheckthe AP view to ensure that both the coronal plane entry point and wireorientation are acceptable. As can be understood with reference to FIGS.3A-3E, multiple cycles of anterior-posterior (AP) and lateral imagingmay be required to confirm the optimal entry point positioning. Thisunpredictable repetition of activities, can be time-consuming,frustrating, costly, and can impact patient outcomes.

Referring now to FIGS. 4, and 5A-5C an example method of aligning adevice during medical procedure involving guide wire insertion during afemoral intramedullary (IM) nailing procedure is described. Unlike theconventional iterative and repetitive method of K-wire positioning andalignment described above, the example method described below employsthe fixation of the anchoring component and relative rotation of therotatable guide component. This fixation and controlled relativerotation provides a method that is deterministic and thus avoids theiterative trial-and-error nature of the conventional method.

FIG. 4 shows a flow chart illustrating the steps in the examplefluoroscopy-based method, and FIGS. 5A-C show images of an examplepositioning and alignment instrument during steps of the procedure. Itis noted that the following method steps shown in FIG. 4 are performedafter having inserted the guidance instrument into the bone, and thatthe following steps do not involve the step of the insertion of thedevice into the bone, and rather recite steps for aligning the devicefor subsequent insertion into the bone. The illustrated method stepstherefore do not pertain to a surgical intervention per se.

Prior to performing the method steps shown in FIG. 4, the positioningand alignment instrument is initially placed, under fluoroscopic imageguidance, at the approximate IM nailing entry point location, which, inthe present non-limiting example, resides at the piriformis fossa orgreater trochanter. Anterior-posterior (AP) images are employed to alignthe positioning and alignment instrument such that at least one deviceguide channel of the guidance component is aligned with theintramedullary canal of the femur, as shown in FIG. 5A. Once thisinitial two-dimensional alignment is satisfactory, the instrument issubjected to a force (as shown in FIG. 2C) to anchor the anchoringprotrusions into the greater trochanter of the femur. FIG. 5B shows anAP image showing the positioning and alignment instrument with theanchoring component anchored to the bone.

As shown in FIG. 5D, the example positioning and guidance instrumentincludes a two-dimensional array of device guide channels, including aplurality of rows 400 (perpendicular to the rotation axis at the distalend of the rotational guide component) and a plurality of columns 405(parallel to the rotation axis at the distal end of the rotational guidecomponent). According to such an instrument configuration, when multiplerows of device guide channels are visible in the AP images, the AP imagemay be employed to select a guide channel row that is best (optimally)aligned with the intramedullary canal, as shown at step 300 in FIG. 4.It will be understood that this step may optionally be performed incases in which the guidance component includes a plurality of rows ofdevice guide channels that are observable in the AP image (the optionalnature of this step is indicated by the dashed flow chart element 300 inFIG. 4). In various example embodiments, the guidance component may onlyinclude a single device guide channel, a single row of device guidechannels, a single column of device guide channels, or a two-dimensionalarray of rows and columns of device guide channels.

As shown in step 305 of FIG. 4, one or more subsequent lateral (oroblique-lateral) images (e.g. images in a perpendicular direction thatincludes the sagittal plane) are then obtained to identify the correctthree-dimensional trajectory for accessing the intramedullary canal. Theguidance component is then rotated relative to the anchoring componentin order to align the guidance component with the intramedullary canal,as shown at step 310. Such a configuration is shown in FIG. 6, where therotational guidance component has been rotationally aligned such thatthe K-wire is axially aligned with the intramedullary canal uponinsertion therein.

In the event that the position and alignment instrument includesmultiple columns of device guide channels (as in FIG. 5D), the deviceguide channels visible in the lateral image may be employed, as shown instep 315 to select the column (while maintain the selection of the row,if performed in step 300) that provides the optimal alignment of thedevice guide channel with the intramedullary canal.

As described above with reference to FIGS. 1A and 1B, the positioningand alignment instrument may include a rotation actuation mechanism, andthe rotation actuation mechanism may be located proximal to, or adjacentto, a handle portion of the anchoring component, such that the rotationactuation mechanism can be actuated single-handedly while holding thehandle.

Unlike the conventional method described with reference to FIGS. 3A-3E,the present example method enables deterministic positioning andalignment of a device without requiring an iterative trial-and-errorbased approach. This is achieved by the fixation of the anchoringcomponent during the initial collection of images, and the subsequentrotation of the guidance component during the acquisition of images froma perpendicular direction, where the guidance component is rotated in anarc that is fixed relative to the anchoring component, such that theinitial alignment in the first direction is preserved and maintainedwhen aligning the remainder of the rotational guidance component in thesecond direction.

Having obtained alignment of the guidance component, using theaforementioned direct and deterministic method, the device may besubsequently guided by the selected device guide channel (i.e. along theselected row and column) for controlled insertion into the bone.

It will understood that the specific implementation shown in FIGS. 1Aand 1B is provided to illustrate one example and non-limitingconfiguration of a positioning and guidance instrument, and otherconfigurations may be employed for other clinical applications. Forexample, in other example implementations, the device channel guides 122need not extend to a distal location that is adjacent to the distal end118 of the anchoring component 110.

In the various examples embodiments described herein, the devicereceived within the device guide channel is a K-wire. However, it willbe understand that a K-wire is disclosed as a non-limiting example of abroad class of devices. Accordingly, the term “device”, as used herein,refers generally to any number of implantable devices, materials andinstruments suitable for bone treatment and/or repair. For example, thedevice may be an implantable device, an insertion tool, a drill bit, aninjection needle, a catheter, or any other surgical instrument.

While the positioning and alignment device illustrated in FIGS. 1A and1B employs two anchoring protrusions, it will be understood that thisspecific configuration provides merely one example implementation, andthat in general the anchoring component may have one or more anchoringprotrusions, provided that the one or more anchoring protrusions aresuitable for anchoring the anchoring component in a fixed position andfixed orientation. For example, FIG. 9 illustrates an exampleimplementation of a single anchoring component 500 having a rectangularelongate segment 505 that enforces a fixed position and orientation whenembedded in bone.

Although the preceding example embodiments involve intramedullarynailing procedures, it will be understood that the embodiments of thepresent disclosure may be applied to, or adapted to, a wide variety ofsurgical procedures, in which tool guide channels are aligned tointernal anatomical or function features, or to features associated withembedded medical devices.

For example, as shown in FIGS. 7 and 8, the positioning and alignmentdevice may be employed to select a suitable position and orientation ofa drill bit that is employed to drill an initial hole to guide thesubsequent insertion of a locking screw into the distal region of an IMnail. Once the distal nail hole is seen as a circle under fluoroscopyand an incision is made, the device can be inserted into the bone. Asshown in FIG. 7, the curvature of the rotatable guidance component isbeneficial to reducing both the amount of the position and alignmentinstrument that lies within the path of the fluoroscopy beam andpotential radiation exposure to the surgeon's hands. Once a correctguide channel is selected, a flexible drill bit can be advanced to makean initial hole for the subsequent insertion of a locking screw. Thiseliminates the need for a radiolucent drill or repeated assessments ofthe drill bit if a free hand technique is utilized. The positioning andalignment device of the aforementioned embodiments could also beutilized, for example, in prophylactic femoral, tibial or humeralnailing, or, for example, any other surgery that involves insertion of asurgical instrument into bone under fluoroscopic guidance.

The specific embodiments described above have been shown by way ofexample, and it should be understood that these embodiments may besusceptible to various modifications and alternative forms. It should befurther understood that the claims are not intended to be limited to theparticular forms disclosed, but rather to cover all modifications,equivalents, and alternatives falling within the spirit and scope ofthis disclosure.

1. A positioning and alignment instrument for guiding insertion of adevice into bone, the positioning and alignment instrument comprising:an anchoring component comprising a proximal portion and a distalportion, wherein said proximal portion comprises a handle, and whereinone or more anchoring protrusions extend from a distal end of saiddistal portion for anchoring said anchoring component into the bone,such that a position and an orientation of said anchoring component isfixed relative to the bone when said anchoring component is anchored tothe bone; and a guidance component mechanically supported by saidanchoring component, said guidance component comprising a device guidechannel for receiving the device and guiding the device towards aninsertion location adjacent to the distal end of said anchoringcomponent; wherein said guidance component is rotatable relative to saidanchoring component about a rotation axis that is located adjacent tothe distal end of said anchoring component, such that the insertionlocation remains adjacent to the distal end of said anchoring componentunder rotation of said guidance component.
 2. The positioning andalignment instrument according to claim 1 further comprising a rotationactuation mechanism for actuating rotation of said guidance component,wherein said rotation actuation mechanism is located proximal to saidhandle such that said rotation actuation mechanism is capable of beingactuated by a user while holding said handle with a single hand.
 3. Thepositioning and alignment instrument according to claim 2 wherein saidrotation actuation mechanism is configured to be actuated by a thumbwhile holding said handle with the single hand.
 4. The positioning andalignment instrument according to claim 3 wherein said rotationactuation mechanism comprises a rotatable knob that is adjacent to saidhandle for actuation by the thumb.
 5. The positioning and alignmentinstrument according to claim 2 further comprising a rotation lockingmechanism for locking a rotation angle of said guidance component. 6.The positioning and alignment instrument according to claim 5 whereinsaid rotation locking mechanism is located proximal to said handle suchthat said rotation locking mechanism is capable of being actuated by theuser while holding said handle with the single hand.
 7. The positioningand alignment instrument according to claim 1 wherein said guidancecomponent is pivotally coupled to said anchoring at a pivot locationthat is adjacent to the distal end of said anchoring component andadjacent to a distal end of said guidance component.
 8. The positioningand alignment instrument according to claim 7 wherein said guidancecomponent comprises a slot having a slot axis that is parallel to adistal portion of said device guide channel, wherein said positioningand alignment instrument further comprises a linkage having a first endthat is pivotally coupled said proximal portion of said anchoringcomponent, and a second end comprising a pin, wherein said pin isreceived in said slot.
 9. The positioning and alignment instrumentaccording to claim 1 wherein said guidance component is rotatablysupported relative to said anchoring component such that said rotationaxis is within 5 mm of the distal end of said anchoring component. 10.The positioning and alignment instrument according to claim 1 whereinsaid guidance component is rotatably supported relative to saidanchoring component such that said rotation axis is within 2 mm of thedistal end of said anchoring component.
 11. The positioning andalignment instrument according to claim 1 wherein a distal portion ofsaid device guide channel is aligned along a device guidance axis, andwherein a proximal portion of said device guide channel deflectsoutwardly relative to said device guidance axis toward said handle. 12.The positioning and alignment instrument according to claim 11 whereinsaid proximal portion is deflected outwardly at an angle of 0 to 30degrees relative to said device guidance axis.
 13. The positioning andalignment instrument according to claim 1 wherein said distal portion ofsaid anchoring component has a rectangular cross-section, wherein a longaxis of said rectangular cross-section is perpendicular to the rotationaxis and wherein said one or more anchoring protrusions extend from thedistal end of said anchoring component.
 14. The positioning andalignment instrument according to claim 1 wherein said proximal portioncomprises a proximal impact receiving surface suitably oriented toreceive an impact for driving said one or more anchoring protrusionsinto the bone.
 15. The positioning and alignment instrument according toclaim 1 further comprising a force coupling tool configured to contactsaid anchoring component and drive said one or more anchoringprotrusions into bone upon the application of a force thereto.
 16. Thepositioning and alignment instrument according to claim 15 wherein saidforce coupling tool is configured to drive said one or more anchoringprotrusions into bone when an impact force is applied thereto.
 17. Theposition and alignment instrument according to claim 16 wherein saidforce coupling tool comprises a distal surface suitable for contactingsaid anchoring component, and wherein said force coupling tool comprisesa proximal surface suitable for receiving an impact, such that when saidforce coupling tool is contacted with said anchoring component and animpact force is delivered to said proximal surface of said forcecoupling tool, the impact force is coupled through said force couplingtool to said anchoring component for driving said one or more anchoringprotrusions into bone.
 18. The positioning and alignment instrumentaccording to claim 15 wherein said force coupling tool is configured torotate said one or more anchoring protrusions while said one or moreanchoring protrusions are driven into bone.
 19. The position andalignment instrument according to claim 18 wherein said force couplingtool comprises a gearbox contacting a proximal portion of said anchoringcomponent, wherein said gearbox houses a gear train configured to rotatesaid one or more anchoring protrusions; wherein a proximal portion ofsaid gearbox comprises a screw that is configured to actuate said geartrain, such that when said screw is rotated during application of alongitudinal force thereto, the longitudinal force is coupled to saidone or more anchoring protrusions during rotation thereof for drivingsaid one or more anchoring protrusions into bone.
 20. The position andalignment instrument according to claim 19 wherein said anchoringcomponent supports one or more rotatable pins extending longitudinallytherethrough, and wherein said one or more rotatable pins extend from adistal end of said anchoring component to respectively form said one ormore anchoring protrusions; and wherein a proximal portion of each pinof said one or more rotatable pins extends from the proximal portion ofsaid anchoring component and is received within a respectivepin-receiving gear of said gear train, such that actuation of said geartrain produces concomitant rotation of said one or more rotatable pins.21. The positioning and alignment instrument according to claim 19wherein said one or more anchoring protrusions are flexible drill bits.22. The positioning and alignment instrument according to claim 21wherein said drill bits are removably attachable to said gearbox,thereby permitting the selectable use of differently-sized drill bits.23. The positioning and alignment instrument according to claim 19wherein said screw is a first screw coupled to a first side of said geartrain, and wherein said gearbox further comprises a second screw coupledto a second side of said gear train, such that rotation of either ofsaid first screw and said second screw causes rotational actuation ofsaid gear train for driving said one or more anchoring protrusions intobone.
 24. The positioning and alignment instrument according to claim 1wherein a distal portion of said guidance component is radiolucent. 25.The positioning and alignment instrument according to claim 1 whereinsaid device guide channel is a first device guide channel, and whereinsaid positioning and alignment instrument further comprises one or moreadditional device guide channels, wherein said one or more additionaldevice guide channels are laterally spaced relative to said first deviceguide channel in a direction that is perpendicular to the rotation axis.26. The positioning and alignment instrument according to claim 1wherein said device guide channel is a first device guide channel, andwherein said positioning and alignment instrument further comprises oneor more additional device guide channels, wherein said one or moreadditional device guide channels are laterally spaced relative to saidfirst device guide channel in a direction that is parallel to therotation axis.
 27. The positioning and alignment instrument according toclaim 1 wherein said guidance component comprises a two-dimensionalarray of guide channels, wherein the two-dimensional array of guidechannels are arranged in two or more rows and two or more columns,wherein said rows arranged perpendicular to the rotation axis, andwherein said columns are arranged parallel to the rotation axis.
 28. Thepositioning and alignment instrument according to claim 1 wherein saiddevice guide channel has a diameter suitable for guiding a Kirschnerwire.
 29. A method of employing fluoroscopy to aligning a device duringa medical procedure, the method comprising, after having employedfluoroscopy, in a first direction, to anchor the positioning andalignment instrument according to claim 1 into bone: obtainingfluoroscopy images of the positioning and alignment instrument in aperpendicular direction; and rotating the guidance component to adesired angle according to the fluoroscopy images; and thereby aligningthe device guide channel for subsequent guidance and insertion of thedevice into the bone.
 30. The method according to claim 29 wherein saiddevice guide channel is a first device guide channel, and wherein theguidance component further comprises one or more additional device guidechannels, wherein said one or more additional device guide channels arelaterally spaced relative to said first device guide channel in adirection that is parallel to said rotation axis, and wherein the methodfurther comprises: prior to obtaining fluoroscopy images of thepositioning and alignment instrument in the perpendicular direction,obtaining fluoroscopy images of the positioning and alignment instrumentin the first direction, and selecting a suitable device guide channelfor guiding the device to a desired entry location.
 31. The methodaccording to claim 29 wherein said device guide channel is a firstdevice guide channel, and wherein the guidance component furthercomprises one or more additional device guide channels, wherein said oneor more additional device guide channels are laterally spaced relativeto said first device guide channel in a direction that is perpendicularto said rotation axis, and wherein the method further comprises:selecting a suitable device guide channel for guiding the device to adesired entry location.
 32. The method according to claim 29 wherein theguidance component further comprises a two-dimensional array of guidechannels, wherein the two-dimensional array of guide channels arearranged in two or more rows and two or more columns, wherein the rowsarranged perpendicular to the rotation axis, and wherein the columns arearranged parallel to the rotation axis, wherein the method furthercomprises: prior to obtaining fluoroscopy images of the positioning andalignment instrument in the perpendicular direction, obtainingfluoroscopy images of the positioning and alignment instrument in thefirst direction, and selecting a suitable column for guiding the deviceto a desired entry location; and when obtaining fluoroscopy images ofthe positioning and alignment instrument in the perpendicular direction,selecting a suitable row for guiding the device to the desired entrylocation; wherein the suitable row and suitable column identify asuitable device guide channel for guiding the device to the desiredentry location.
 33. The method according to claim 29 wherein the deviceis a Kirschner wire and the medical procedure involves the insertion anddrilling of the Kirschner wire into the intramedullary canal of thebone.
 34. The method according to claim 29 wherein the device is a drillbit and the medical procedure involves the insertion and drilling of thedrill bit into the bone in order to generate a pilot hole for subsequentinsertion of a locking screw into an intramedullary nailing.
 35. Themethod according to claim 29 wherein the perpendicular direction is ananterior-posterior direction.